Trials / Completed
CompletedNCT05329077
Pulsenmore ES Device, Efficacy and Safety Assessment
A Study to Assess the Safety and Efficacy of Pulsenmore ES Home Ultrasound Device in Pregnant Women
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 188 (actual)
- Sponsor
- PulseNmore · Industry
- Sex
- Female
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This is a multicenter, prospective, investigational device study designed to evaluate: The safety, feasibility, and accuracy of the device, when used by pregnant individuals
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Pulsenmore ES home ultrasound device | Pregnant participants will use Pulsenmore ES device to assess the safety and the efficacy of the device in monitoring fetal parameters |
Timeline
- Start date
- 2022-04-14
- Primary completion
- 2023-06-09
- Completion
- 2023-11-11
- First posted
- 2022-04-14
- Last updated
- 2023-11-30
Locations
4 sites across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT05329077. Inclusion in this directory is not an endorsement.